Quality Systems and Compliance Manager | Galway | Permanent.
Our client, a Medical Diagnostic company here in Galway are looking for a Quality Systems and Compliance Manager to join their team on a permanent basis.
Within this role you will work across the quality system lifecycle from design through post market surveillance. This role will be within the Infectious Disease Emerging Market (IDEM) organisation.
You will be responsible for:
- Leading and coordinating the QMS Integration project across both manufacturing and commercial sites, working with the Site project leads to ensure project plans are in place and tracking to milestone targets.
- Establishing, implementing, and maintaining the IDEM Quality Management System, providing direction and support to all functions, manufacturing sites, commercial entities, in areas of design quality, production and process controls, distribution quality, post market activities.
- Keep the IDEM Leadership up to date on all changes to the quality system and provide updates of any system gaps.
- Leading and co-ordinate other strategic quality projects such as the deployment of automated quality systems at IDEM sites, collaborating in partnership with ARDx divisional and IT leads to ensure requirements/expectations are aligned.
- Drive improvements and standardization in all the key quality system areas across all IDEM sites.
- Work effectively with cross functional colleagues to ensure that the IDEM quality system meets the Companies Polices and Standards as well as all external regulatory requirements.
- Ensure that all staff have the knowledge and understanding of all quality system requirements and provide the appropriate training to those who are accountable for the delivery of quality system requirements.
- Work closely withing the IDEM RA team to understand changes in regulatory requirements.
- Bachelor of Science/Engineering or related discipline
- Minimum 10 years work experience, including at least 5 years in a regulated environment (IVD/Medical Devices/Pharma), with minimum of 3 years in a Quality management role.
- Strong understanding and experience in the implementation of ISO 13485, ISO 14971, IVDR/MDR
- Quality system requirements, FDA QSR’s, as well as key global regulations – TGA/PMDA/NMPA/WHO .
- Ability to build an effective quality system, and efficient processes that support BU/Site business objectives
If you are interested in this role apply with an updated CV to Rebecca O'Connor at email@example.com
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